510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820537Substantially Equivalent

Ultrasonic Toothbrush

Ultrasonic Plaque Control Laboratories, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820537 is the FDA 510(k) clearance record for ULTRASONIC TOOTHBRUSH, a class I device, cleared for Ultrasonic Plaque Control Laboratories on under FDA product code JEQ (Toothbrush, Powered). FDA records list one 510(k) clearance for Ultrasonic Plaque Control Laboratories. As of , FDA records show no recalls naming K820537.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JEQ Toothbrush, Powered
Regulation
21 CFR 872.6865
Device class
Class I
Review panel
Dental
Applicant
Ultrasonic Plaque Control Laboratories 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JEQ

Trailing 12 months

FDA records hold no clearances under product code JEQ in the trailing twelve months.

FDA records show no clearances under product code JEQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JEQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260